WO2023274659A1 - Dispositif médical implantable, système de communication d'implant et procédé de mise à jour d'un code exécutable d'un dispositif médical implantable - Google Patents

Dispositif médical implantable, système de communication d'implant et procédé de mise à jour d'un code exécutable d'un dispositif médical implantable Download PDF

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Publication number
WO2023274659A1
WO2023274659A1 PCT/EP2022/065040 EP2022065040W WO2023274659A1 WO 2023274659 A1 WO2023274659 A1 WO 2023274659A1 EP 2022065040 W EP2022065040 W EP 2022065040W WO 2023274659 A1 WO2023274659 A1 WO 2023274659A1
Authority
WO
WIPO (PCT)
Prior art keywords
communication interface
wireless communication
executable code
implantable medical
medical device
Prior art date
Application number
PCT/EP2022/065040
Other languages
English (en)
Inventor
Thomas Doerr
Original Assignee
Biotronik Se & Co. Kg
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biotronik Se & Co. Kg filed Critical Biotronik Se & Co. Kg
Priority to EP22730575.2A priority Critical patent/EP4363046A1/fr
Publication of WO2023274659A1 publication Critical patent/WO2023274659A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
    • A61N1/37264—Changing the program; Upgrading firmware
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37235—Aspects of the external programmer
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Definitions

  • BIOTRONIK SE & Co. KG Applicant: BIOTRONIK SE & Co. KG
  • the invention relates to an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator.
  • the invention further relates to an implant communication system.
  • the invention relates to a computer implemented method for updating an executable code of an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator.
  • Active electronic implants are customarily equipped with Bluetooth Low Energy radios to enable communication with commercially available smartphones and tablets.
  • firmware updates of implantable medical devices including the Bluetooth stack update are performed on implants with a programming device.
  • the disadvantage of the current solution of updating the Bluetooth stack by means of a programming device is that the implant carrier has to be called in for the update thus resulting in significant costs and effort for the update.
  • the time period for an area-wide update of all implants is very long. In the case of urgent updates, an official recall might have to take place in order to update all implants quickly.
  • the object is solved by an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator having the features of claim 1.
  • the object is solved by a computer implemented method for updating an executable code of an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator having the features of claim 11.
  • the present invention provides an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator.
  • the implantable medical device comprises a diagnostic and/or therapeutic control unit and a wireless communication interface, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices, in particular smartphones and/or tablet computing devices.
  • the implantable medical device comprises a first memory area, in which executable code for controlling the diagnostic and/or therapy control unit is stored.
  • the implantable medical device comprises a second memory area, in which executable code for controlling the wireless communication interface is stored, wherein the software and/or hardware of the wireless communication interface is configured to update the executable code of the wireless communication interface via the wireless communication interface.
  • the present invention further provides an implant communication system, comprising the implantable medical device according to the present invention, a programmer configured to communicate with the implantable medical device using inductive communication or medical RF communication and a consumer mobile communication device, in particular a smartphone or tablet computing device, configured to communicate with the implantable medical device in a frequency band and/or using a communication protocol supported by the consumer mobile communication device.
  • the present invention further provides a computer implemented method for updating an executable code of an implantable medical device, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator.
  • the method comprises providing a diagnostic and/or therapeutic control unit and providing a wireless communication interface operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices, in particular smartphones and/or tablet computing devices.
  • the method comprises storing executable code for controlling the diagnostic and/or therapy control unit in a first memory area and storing executable code for controlling the wireless communication interface in a second memory area.
  • the method moreover comprises updating the executable code of the wireless communication interface by means of a software and/or hardware configuration of the wireless communication interface via the wireless communication interface.
  • the Bluetooth stack i.e. the software that controls the Bluetooth communication in the implant is updated regularly. According to the present invention the update can be performed wirelessly such that the patient does not have to be called in.
  • the update of the communication unit of the implant thus does not have any influence on the therapy control of the implant.
  • the first memory area can hence be updated without the second memory area being affected by said update. This is a risk-mitigating measure to prevent an update of the Bluetooth stack from negatively influencing the therapy function of the implant.
  • An example of a diagnostic device is a heart rhythm monitor, which in the event of abnormalities makes ECG recordings that can later be evaluated by a physician.
  • An example of a therapy device is a cardiac pacemaker which has no diagnostic function but provides solely therapy. Many devices however have a diagnostic as well as a therapeutic function.
  • the implantable medical device comprises at least one further wireless communication interface configured to update the executable code for controlling the diagnostic and/or therapeutic control unit, wherein the at least one further wireless communication interface comprises an inductive communication interface and/or a MICS band communication interface.
  • the diagnostic and/or therapeutic control unit can be safely updated via the at least one further wireless communication interface which is not accessible via the consumer mobile communication device.
  • the at least one further wireless communication interface is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit, wherein an authentication of the update is performed via the inductive communication interface.
  • the authentication of the update is thus either performed by a physician or by the patient, wherein said update cannot be performed via Bluetooth connectivity such that an unintended and/or an authenticated update attempt is effectively inhibited.
  • the implantable medical device is configured to use a first authentication mechanism for authenticating an update of the executable code for controlling the diagnostic and/or therapeutic control unit, and wherein the implantable medical device is configured to use a second authentication mechanism for authenticating an update of the executable code for controlling the wireless communication interface.
  • the first authentication mechanism for authenticating an update of the executable code for controlling the diagnostic and/or therapeutic control unit and the second authentication mechanism for authenticating an update of the executable code for controlling the wireless communication interface updates of the diagnostic and/or therapeutic control unit and the wireless communication interface are effectively separately, i.e. independently authenticated, thus adding an additional layer of security.
  • the diagnostic and/or therapeutic control unit is configured to prohibit an update of the executable code for controlling the wireless communication interface if a predetermined condition is met, in particular if higher-priority system tasks are pending and/or if an unauthenticated update attempt is performed.
  • the diagnostic and/or therapeutic control unit is thus configured to override update requests for updating in the executable code for controlling the wireless communication interface if said predetermined condition is met.
  • the wireless communication interface uses an authentication and/or data encryption method supported by consumer mobile communications devices, in particular smartphones and/or tablet computing devices. This advantageously enables the usage of existing standards for authentication and/or data encryption method supported by consumer mobile communications devices ensuring a secure connection and data transferred to the implantable medical device.
  • the wireless communication interface is a, in particular software-controlled, Bluetooth, Bluetooth Low Energy and/or Bluetooth Mesh communication interface. This ensures compatibility with a wide range of consumer mobile communications devices.
  • the consumer mobile communication device is configured to authenticate an update of the executable code for controlling the wireless communication interface using an app connected to the implantable medical device.
  • the updates of the executable code for controlling the wireless communication interface can thus be easily performed by the patient using the app installed in the consumer mobile communications device.
  • the programmer is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit. The authentication of the update is thus either performed by a physician or by the patient, wherein said update cannot be performed via Bluetooth connectivity such that an unintended and/or an authenticated update attempt is effectively inhibited.
  • implantable medical device configured to exchange data with an external communication device
  • computer implemented method for updating an executable code of an implantable medical device are also disclosed for the computer implemented method for updating an executable code of an implantable medical device and vice versa.
  • Fig. 1 shows a schematic view of an implantable medical device according to a preferred embodiment of the invention
  • Fig. 2 shows a schematic view of an implant communication system according to the preferred embodiment of the invention.
  • Fig. 3 shows a flowchart of a computer implemented method for transferring data between an implantable medical device and an external communication device according to the preferred embodiment of the invention.
  • the implantable medical device 10 of Fig. 1 in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator comprises a diagnostic and/or therapeutic control unit 12 and a wireless communication interface 14, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices 16, in particular smartphones and/or tablet computing devices.
  • the implantable medical device 10 further comprises a first memory area 18, in which executable code for controlling the diagnostic and/or therapy control unit 12 is stored.
  • the implantable medical device 10 comprises a software-controlled therapy controller, whose executable code is stored in the first memory area 18.
  • the implantable medical device 10 moreover comprises a second memory area 20, in which executable code for controlling the wireless communication interface 14 is stored.
  • the implantable medical device 10 comprises a software-controlled Bluetooth low energy BLE radio, the executable code of which is stored in a second memory area 20.
  • the wireless communication interface 14 may also support Bluetooth and/or Bluetooth Mesh radio.
  • the BLE radio is connected to a second antenna 28. Both memory areas are separated from each other in the architecture of the memory access in such a way that at least the second memory area 20, i.e. the BLE radio cannot directly write-access the first memory area 18.
  • the software and/or hardware of the wireless communication interface 14 is configured to update the executable code of the wireless communication interface 14 via the wireless communication interface 14.
  • the implantable medical device 10 comprises at least one further wireless communication interface 22 configured to update the executable code for controlling the diagnostic and/or therapeutic control unit 12, wherein the at least one further wireless communication interface 22 comprises an inductive communication interface 22a and/or a MICS band communication interface 22b.
  • the diagnostic and/or therapeutic control unit 12 is connected to a first antenna 26 and is configured to exchange authentication information between an authorized external device and the therapy controller.
  • the at least one further wireless communication interface 22 is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit 12, wherein an authentication of the update is performed via the inductive communication interface 22a.
  • the patient thus authorizes the update via a separate device, i.e. via the inductive communication interface 22a.
  • a message is displayed on the patient’s consumer mobile communication device 16 e.g. "there is an update available for your implant. Please authorize the update with your patient device.”
  • the patient device i.e. the inductive communication interface 22a is placed in the vicinity of the implant. Authentication then takes place in the implant so that the implant accepts the update.
  • the implantable medical device 10 is configured to use a first authentication mechanism for authenticating an update of the executable code for controlling the diagnostic and/or therapeutic control unit 12. In addition, the implantable medical device 10 is configured to use a second authentication mechanism for authenticating an update of the executable code for controlling the wireless communication interface 14.
  • the diagnostic and/or therapeutic control unit 12 is configured to prohibit an update of the executable code for controlling the wireless communication interface 14 if a predetermined condition is met, in particular if higher-priority system tasks are pending and/or if an unauthenticated update attempt is performed.
  • the wireless communication interface 14 uses an authentication and/or data encryption method supported by consumer mobile communications devices 16, in particular smartphones and/or tablet computing devices.
  • Fig. 2 shows a schematic view of an implant communication system 1 according to the preferred embodiment of the invention.
  • the implant communication system 1 comprises the implantable medical device 10 according to the present invention. Furthermore, the implant communication system 1 comprises a programmer 24 configured to communicate with the implantable medical device 10 using inductive communication or medical RF communication.
  • the implant communication system 1 comprises a consumer mobile communication device 16, in particular a smartphone or tablet computing device, configured to communicate with the implantable medical device 10 in a frequency band and/or using a communication protocol supported by the consumer mobile communication device 16.
  • a consumer mobile communication device 16 in particular a smartphone or tablet computing device, configured to communicate with the implantable medical device 10 in a frequency band and/or using a communication protocol supported by the consumer mobile communication device 16.
  • the consumer mobile communication device 16 is configured to authenticate an update of the executable code for controlling the wireless communication interface 14 using an app connected to the implantable medical device 10. Furthermore, the programmer 24 is configured to authenticate an update of the executable code for controlling the diagnostic and/or therapeutic control unit 12.
  • Fig. 3 shows a flowchart of a computer implemented method for transferring data between an implantable medical device 10 and an external communication device according to the preferred embodiment of the invention.
  • the computer implemented method for updating an executable code of an implantable medical device 10, in particular a diagnostic monitoring device, a pacemaker, a defibrillator and/or a neuro-stimulator comprises providing SI a diagnostic and/or therapeutic control unit 12 and providing S2 a wireless communication interface 14, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices 16, in particular smartphones and/or tablet computing devices.
  • the method comprises storing S3 executable code for controlling the diagnostic and/or therapy control unit 12 in a first memory area 18 and storing S4 executable code for controlling the wireless communication interface 14 in a second memory area 20. Moreover, the method comprises updating S5 the executable code of the wireless communication interface 14 by means of a software and/or hardware configuration of the wireless communication interface 14 via the wireless communication interface 14. Further embodiments:
  • a computer implemented method for updating a medical device implanted into the human or animal body comprising providing a diagnostic and/or therapeutic control unit 12 and providing a wireless communication interface 14, operating in a frequency band and/or using a communication protocol supported by consumer mobile communications devices 16, in particular smartphones and/or tablet computing devices.
  • the method further comprises storing executable code for controlling the diagnostic and/or therapy control unit 12 in a first memory area 18 and storing executable code for controlling the wireless communication interface 14 in a second memory area 20.
  • the method comprises updating the executable code of the wireless communication interface 14 by means of a software and/or hardware configuration of the wireless communication interface 14 via the wireless communication interface 14.
  • implantable medical device 12 diagnostic and/or therapeutic control unit

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

L'invention se rapporte à un dispositif médical implantable (10), en particulier à un dispositif de surveillance de diagnostic, à un stimulateur cardiaque, à un défibrillateur et/ou à un neuro-stimulateur, comprenant une unité de commande de diagnostic et/ou de thérapie (12), une interface de communication sans fil (14) fonctionnant dans une bande de fréquences et/ou à l'aide d'un protocole de communication pris en charge par des dispositifs de communication mobiles de consommateurs (16), en particulier des téléphones intelligents et/ou des tablettes informatiques, une première zone de mémoire (18), dans laquelle est enregistré un code exécutable servant à commander l'unité de commande de diagnostic et/ou de thérapie (12), et une seconde zone de mémoire (20), dans laquelle est enregistré un code exécutable servant à commander l'interface de communication sans fil (14), le logiciel et/ou le matériel de l'interface de communication sans fil (14) étant conçu pour mettre à jour le code exécutable de l'interface de communication sans fil (14) par l'intermédiaire de l'interface de communication sans fil (14). L'invention se rapporte en outre à un système de communication d'implant (1), à un procédé de mise à jour d'un code exécutable d'un dispositif médical implantable (10) et à un programme informatique.
PCT/EP2022/065040 2021-06-29 2022-06-02 Dispositif médical implantable, système de communication d'implant et procédé de mise à jour d'un code exécutable d'un dispositif médical implantable WO2023274659A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP22730575.2A EP4363046A1 (fr) 2021-06-29 2022-06-02 Dispositif médical implantable, système de communication d'implant et procédé de mise à jour d'un code exécutable d'un dispositif médical implantable

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21182298.6 2021-06-29
EP21182298 2021-06-29

Publications (1)

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WO2023274659A1 true WO2023274659A1 (fr) 2023-01-05

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PCT/EP2022/065040 WO2023274659A1 (fr) 2021-06-29 2022-06-02 Dispositif médical implantable, système de communication d'implant et procédé de mise à jour d'un code exécutable d'un dispositif médical implantable

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EP (1) EP4363046A1 (fr)
WO (1) WO2023274659A1 (fr)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100161003A1 (en) * 2007-05-28 2010-06-24 Patrik Malmberg Implantable medical device
US20200121937A1 (en) * 2016-01-29 2020-04-23 Medtronic, Inc. Facilitating integrity of telemetry connectivity between a medical device and a remote device
US20200252436A1 (en) * 2019-01-31 2020-08-06 Medtronic, Inc. Establishing a secure communication link

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100161003A1 (en) * 2007-05-28 2010-06-24 Patrik Malmberg Implantable medical device
US20200121937A1 (en) * 2016-01-29 2020-04-23 Medtronic, Inc. Facilitating integrity of telemetry connectivity between a medical device and a remote device
US20200252436A1 (en) * 2019-01-31 2020-08-06 Medtronic, Inc. Establishing a secure communication link

Also Published As

Publication number Publication date
EP4363046A1 (fr) 2024-05-08

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